Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) in HIV Uninfected Adults

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.

Key facts

Study ID

NCT00071851

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

180

Starts

2003-12-01

Expected to finish

2005-10-01

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Understanding of vaccination procedure
• Willing to receive HIV test results and provide informed consent
• Good general health
• HIV negative
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
• Not pregnant and agrees to use acceptable forms of contraception

You may not qualify if…

• HIV vaccines or placebo in a prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to study
• Blood products within 120 days prior to study
• Immunoglobulin within 60 days prior to study
• Live attenuated vaccines within 30 days prior to study
• Investigational research agents within 30 days prior to study
• Medically indicated subunit or killed vaccines within 14 days prior to study
• Current anti-tuberculosis prophylaxis or therapy
• Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
• Autoimmune disease or immunodeficiency
• Active syphilis infection
• Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
• Diabetes mellitus; a participant with past gestational diabetes is not excluded
• Thyroid disease, including removal of thyroid and diagnoses requiring medication
• Serious angioedema
• Hypertension
• Diagnosis of bleeding disorder
• Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
• Seizure disorder requiring medication within the last 3 years
• Absence of the spleen
• Mental illness that would interfere with compliance with the protocol
• Pregnant or breastfeeding
• Two or more elevated liver function tests

Where it is running

• Alabama Vaccine CRS — Birmingham, Alabama, United States
• San Francisco Vaccine and Prevention CRS — San Francisco, California, United States
• Project Brave HIV Vaccine CRS — Baltimore, Maryland, United States
• Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore — Baltimore, Maryland, United States
• Brigham and Women's Hosp. CRS — Boston, Massachusetts, United States
• Fenway Community Health Clinical Research Site (FCHCRS) — Boston, Massachusetts, United States
• Saint Louis Univ. School of Medicine, HVTU — St Louis, Missouri, United States
• NY Blood Ctr./Union Square CRS — New York, New York, United States
• HIV Prevention & Treatment CRS — New York, New York, United States
• Univ. of Rochester HVTN CRS — Rochester, New York, United States
• NY Blood Ctr./Bronx CRS — The Bronx, New York, United States
• Miriam Hospital's HVTU — Providence, Rhode Island, United States
• Vanderbilt Vaccine CRS — Nashville, Tennessee, United States
• FHCRC/UW Vaccine CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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